MODIFICATION TO ISOBAR SPINAL SYSTEM— 510(k) K000020

Clearance details

Applicant

Encore Orthopedics, Inc.

Product code

Code MNH

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2000-01-04

Decision date

2000-02-03

Decision

Substantially Equivalent

Clearance type

Special

Location

Austin, TX, US

• K162066 — Reliance Spinal Screw System2016-12-02
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• K162143 — FixxSure® X-Link2016-09-23
• K161151 — Spinal fixation system2016-09-21
• K162189 — ANAX 5.5 Spinal System2016-08-30

• K032905 — 3DKNEE POROUS COATED FEMORAL COMPONENT2004-07-06
• K020114 — 3D KNEE2002-07-12
• K020741 — UNICONDYLAR KNEE2002-06-04
• K020236 — MODIFICATION TO PASS SPINAL SYSTEM2002-02-14
• K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP2002-02-11

Injury

978

Malfunction

793

Total

1,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →